Apparatus and method for the removal and containment of human waste excretion

ABSTRACT

The present invention relates to an apparatus for the removal and containment of human waste products from the effected area of incontinent patients. The apparatus and process encapsulates the areas of the body where urine and fecal matter are excreted. In particular, the present invention is directed to an apparatus for the containment and removal of human waste products, comprising: a receptacle; a vacuum connection to apply force for attaching the receptacle to the patient; and a vacuum dispersion membrane to provide mechanical support to the skin so as to minimize tensile force applied to the skin.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of, relates to, and claims thebenefit of the earlier filing date and priority of U.S. application Ser.No. 12/789,220, filed May 27, 2010, now U.S. Pat. No. 8,454,568, whichinvention relates to, and is entitled to the benefit of the earlierfiling date and priority of U.S. Application No. 61/071,597 filed May27, 2009, which are herein incorporated by reference as if fully setforth.

FIELD OF THE INVENTION

The present invention relates to a noninvasive apparatus and process forthe removal and containment of human waste excretion by collecting andflushing bodily excretions away from the patient while maintaining ahigh degree of cleanliness within the effected area. This process ismade possible through the use of a receptacle that is effectivelyattached to the patient using vacuum. The vacuum also serves as a sealfor isolating the treated region from the outside environment. Aflushing process is then contained within the treatment region so as tokeep the effected area clean and moisturized. An embodiment of thisinvention may be applied to individuals who have undergone ostomysurgeries, whereby a vacuum seal can be used to enhance the attachmentof an excrement collection device (such as, but not limited to, anostomy bag) and provide sealing capability of the collection device soas to help prevent leakage. One novel aspect of an embodiment of thisinvention is the application of vacuum beneath a porous membrane thatmakes contact with the skin. The presence of vacuum and the porousmembrane allows for attachment of the apparatus to the patient withminimal stress applied to the skin that could otherwise be injurious.

BACKGROUND OF THE INVENTION

Incontinence patients, due to the condition of not being able to controlthe bodily excretion of urine and fecal matter, are often faced withtreatment options that have major adverse side effects. For bed-riddenpatients, treatment options often include the utilization of diapers,diaper-like garments or other methods that result in skin exposure tourine and fecal matter. Considering the unpleasant presence of odor andsoiled linens, along with prevalent breakdown of the skin, which oftencauses open wounds and infection, there is a need to provide a moreeffective and economical treatment for incontinent patients. There isalso a need to provide a treatment option for those under “end of life”care where comfort and dignity is paramount. The later scenario ofteninvolves in-home treatment by family members whose physical andemotional strains are further impacted by the physical demands offrequent diaper replacement and associated cleaning routines of thesebody areas. These cleansed skin areas typically degrade due to exposureto urine and fecal matter, often resulting in contaminated open wounds.The implementation of the fully automated apparatus and processesembodied herein offers a dignified, highly efficient, labor free andcost effective means of treating this condition with dignity, whilealleviating the physical demands and sleep interruption associated withthe changing of diapers.

The use of catheters for treating urinary incontinence often results inpain and high exposure to infection. The implementation of the fullyautomated apparatus and processes embodied herein offers a comfortablealternative to catheters while minimizing exposure to infection.

There is a large population of spinal and brain injury patients thatrequire complete immobility over a long term. Once some degree ofmobility is restored, these patients typically endure many months ofwound care treatment to repair skin breakdown attributed to exposure tobodily excretions. The apparatus and processes embodied herein wouldeliminate the need for follow-on wound care once mobility is restored.

The physical lift demands and spillage associated with obese patientsutilizing bed pans could be simply eliminated through the use of theapparatus and processes embodied herein.

There is a large population of ostomy patients who are plagued withprevalent odor and bag leakage problems as well as skin irritations.These issues could be easily and cost effectively resolved through theuse of the apparatus embodied herein.

It is therefore an advantage of some, but not necessarily all,embodiments of the present invention to provide an apparatus and processfor the flushing of human waste products within the effected area thatprovides patient comfort, preserves skin integrity, reduces wound careand alleviates physical exertion of care givers associated with changingdiapers and cleaning affected areas.

Additional advantages of various embodiments of the invention are setforth, in part, in the description that follows and, in part, will beapparent to one of ordinary skill in the art from the description and/orfrom the practice of the invention.

SUMMARY OF THE INVENTION

Responsive to the foregoing challenges, Applicant has developed aninnovative apparatus for the removal and containment of human wasteproducts from a patient comprising a receptacle having an interior andan exterior surface, a vacuum connection extending from the exteriorsurface to the interior surface of the receptacle to apply vacuum forattaching the receptacle to the patient, and a vacuum dispersionmembrane disposed at the intersection of the vacuum connection and thepatient to provide mechanical support to the skin and to minimizetensile force applied to the skin at the point of attachment of thereceptacle. The apparatus may also comprise one or more of an inletextending from the exterior surface to the interior surface of thereceptacle for introducing a flushing fluid to an interior of thereceptacle, a nozzle disposed on the interior surface of the receptacleand in fluid communication with the inlet for dispersing the flushingfluid within the receptacle, and/or an outlet extending from theinterior surface to the exterior surface of the receptacle allowingfluids, gasses and contaminants to exit the receptacle.

The apparatus or receptacle may attached to a collection device, whereinthe collection device is an ostomy bag, and further comprise a portdisposed on the exterior surface of the receptacle. The vacuumdispersion membrane may be a textile, natural, synthetic, a polymer, orany other suitable material. The apparatus may further comprise a fecaldetector for sensing the presence of fecal matter in the receptacle.

An embodiment of the present invention is an apparatus for the removaland containment of human waste products from a patient comprising areceptacle having an interior and an exterior surface, an inletextending from the exterior surface to the interior surface of thereceptacle for introducing a flushing fluid to an interior of thereceptacle, an outlet extending from the exterior surface to theinterior surface of the receptacle allowing fluids, gasses andcontaminants to exit the receptacle, a vacuum connection extending fromthe exterior surface to the interior surface of the receptacle to applyvacuum for attaching the receptacle to the patient, and a vacuumdispersion membrane disposed at the intersection of the vacuumconnection and the patient's skin to provide mechanical support to theskin so as to minimize tensile force applied to the skin. The apparatusmy further comprise a nozzle disposed on the interior surface of thereceptacle and in fluid communication with the inlet for dispersing theflushing fluid within the receptacle and/or a fecal detector for sensingthe presence of fecal matter in the receptacle. The receptacle may beattached to a collection device, and the collection device may be anostomy bag.

An embodiment of the present invention is an apparatus for the removaland containment of human waste products from a patient comprising areceptacle having an interior and an exterior surface, an inletextending from the exterior surface to the interior surface of thereceptacle for introducing a flushing fluid to an interior of thereceptacle, a nozzle disposed on the interior surface of the receptacleand in fluid communication with the inlet for dispersing the flushingfluid within the receptacle, an outlet extending from the exteriorsurface to the interior surface of the receptacle allowing fluids,gasses and contaminants to exit the receptacle, a vacuum connectionextending from the exterior surface to the interior surface of thereceptacle to apply vacuum for attaching the receptacle to the patient,and a vacuum dispersion membrane disposed at the intersection of thevacuum connection and the patient's skin to provide mechanical supportto the skin so as to minimize tensile force applied to the skin.

An embodiment of the present invention is an innovative apparatus forthe removal and containment of human waste products from the effectedarea, comprising a receptacle that attaches to the body; an inlet forintroducing flushing fluids and air flow; an outlet for the drainage offlushing fluid, bodily excretions and gases; and a vacuum seal forattaching and holding the receptacle in place, while isolating theinternal receptacle region from the outside environment. It is worthnoting that an antimicrobial cleaning agent could be used as a flushingfluid. It is also important to note that the vacuum seal and membraneaccording to an embodiment of the invention are well suited forimproving the attachment and sealing aspects of ostomy interfacesbetween the skin and excrement collection devices such as ostomy bags.

Applicant has also developed an innovative method for mixing theflushing fluid with air so as to enhance solubility of excretions whileminimizing the consumption of flushing fluids. The flushing fluid is amixture of components that may supply nutrients, moisturizers andantimicrobial solutions to the skin and is designed to provide aprotective layer over the skin to serve as a barrier againstcontaminants and irritants.

The present invention relates to an apparatus for the removal andcontainment of human waste products from the effected area ofincontinent patients. The apparatus and process encapsulates the areasof the body where urine and fecal matter are excreted, flushescontaminants from the area and cleanses these areas. The flushing mediamay be an antimicrobial cleanser and/or contain nutrients that clean,moisturize and protect the skin from contamination. The process iscontrolled using an automated system controller. In particular, thepresent invention is directed to an apparatus for the containment andremoval of human waste products, comprising: a receptacle; an inlet forintroducing a flushing fluid to the interior of the receptacle; a nozzlearrangement for dispersing the flushing fluid within the receptacle; anoutlet for fluids, gasses and contaminants to exit the receptacle; avacuum connection to apply force for attaching the receptacle to thepatient; a vacuum dispersion membrane to provide mechanical support tothe skin so as to minimize tensile force applied to the skin; and afecal detector for sensing the presence of fecal matter internal to thereceptacle

Embodiments of the present invention also relate to an apparatus forattaching and sealing an excrement collection device (ostomy bag) to theexterior skin of the human body. This allows for reliable sealing andcontainment of liquids, solids and gases coupled with easy removal andreattachment of the collection device. The apparatus may comprise areceptacle comprising an interface flange for attachment of an ostomybag or may be a single unit having an interface flange integral to theostomy bag. A vacuum dispersion membrane may be employed to minimizetensile stress of the skin. A means of easily dispersing antimicrobial,moisturizing and nutrients to the stoma may be employed so as tomaintain hygiene and physical integrity of the stoma and surroundingskin if exposed. An adsorption provision for containing vapor leakage(odors) may be employed. The apparatus may have an integral vacuumcontrol unit so as to eliminate the need for a tethered vacuum source.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory only,and are not restrictive of the invention as claimed. The accompanyingdrawings, which are incorporated herein by reference, and whichconstitute a part of this specification, illustrate certain embodimentsof the invention and, together with the detailed description, serve toexplain the principles of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to assist the understanding of this invention, reference willnow be made to the appended drawings, in which like reference charactersrefer to like elements. The drawings are exemplary only, and should notbe construed as limiting the invention.

FIG. 1 is a cross-sectional view of an apparatus for the removal andcontainment of human waste products from the effected area in accordancewith an embodiment of the present invention, depicting the femalereceptacle and its associated components.

FIG. 2 is a cross-sectional view of an apparatus for the removal andcontainment of human waste products from the effected area in accordancewith an embodiment of the present invention, depicting the malereceptacle and its associated components.

FIG. 3 is a cross-sectional view of an apparatus for the removal andcontainment of human waste products from the effected area in accordancewith an embodiment of the present invention, depicting a fecal detectorand its associated components.

FIG. 4 is a cross-sectional view of an apparatus for attaching andsealing an excrement collection device (ostomy bag) in accordance withan embodiment of the present invention, depicting a sealing interfacebetween the skin tissue and collection device (ostomy bag).

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Reference will now be made in detail to an embodiment of the presentinvention, an example of which is illustrated in the accompanyingdrawings. With reference to FIG. 1, apparatus 10 for the removal andcontainment of human waste products from the effected area may comprisereceptacle 100 having an interior surface facing the patient's skin andan exterior surface facing away from the patient's skin, with inlet 110extending from the exterior surface to the interior surface ofreceptacle 100 for introducing flushing fluids 115 (which may or may notbe mixed with air) into the interior of receptacle 100, nozzle 120disposed on the interior surface of receptacle 100 and in fluidcommunication with inlet 110 for introducing and dispersing flushingfluid 115 into the interior of receptacle 100, and outlet 130 extendingfrom the exterior surface to the interior surface of receptacle 100 forallowing fluids, gasses and/or contaminants to exit from the interior ofreceptacle 100. Apparatus 10 also comprises vacuum connection 140extending from the exterior surface to the interior surface ofreceptacle 100 so that vacuum may be applied between a portion of theinterior surface of receptacle 100 and the patient's skin for sealingand holding receptacle 100 in place, and vacuum dispersion membrane 150disposed at the interface of vacuum connection 140 to the patient'sskin, to support the skin so as to minimize tensile force applied to theskin. Vacuum dispersion membrane 150 may be any suitable porous orpermeable membrane allowing air, gas, fluid, etc. to pass through, whilemaintaining a structure that reduces the effect of a direct vacuumapplied to the patient's skin. A lack of skin support will cause injuryto the skin due to stretching. Applicant's invention helps preserve thecondition of the skin by imposing minimal tensile force through the useof a porous membrane, beneath which, vacuum is applied. Vacuumdispersion membrane 150 may be a porous medium or a porous materialcomprising a solid, which may be referred to as a frame or matrix,permeated by an interconnected network of pores or voids which may befilled with a fluid (liquid or gas). Usually both the solid matrix andthe pore network (also known as the pore space) are assumed to becontinuous, so as to form two interpenetrating continua such as in asponge. The membrane may be a natural material, synthetic, or of anyother suitable composition. The membrane may be composed of a fabric, orcloth, or any other suitable textile, ceramic, polymer, and/or permeableand/or porous material. This feature is one aspect to avoiding injury tothe skin.

With reference to FIG. 2, the apparatus 10 for the removal andcontainment of human waste products from the effected area, whenconfigured for a male, may comprise two separate receptacles; receptacle100 for the removal of male urine comprising inlet 110 for flushingfluids (which may or may not be mixed with air) to enter receptacle 100,nozzle 120 for dispersing flushing fluid 115 within receptacle 100,outlet 130 allowing fluids, gasses and/or contaminants to exitreceptacle 100, vacuum connection 140 so that vacuum can be applied forholding receptacle 100 in place, and vacuum dispersion membrane 150 tosupport the skin so as to minimize tensile force applied to the skin, asdescribed in detail above. A second receptacle 200 for receiving fecalexcretion from a male patient may comprise inlet 110 for flushing fluids115 (which may or may not be mixed with air) to enter receptacle 200,nozzle 120 for dispersing flushing fluid 115 within the receptacle,outlet 130 allowing fluids, air and/or contaminants to exit receptacle200, vacuum connection 140 so that vacuum can be applied for sealing andholding receptacle 200 in place, and vacuum dispersion membrane 150 todistribute vacuum force to the skin so as to minimize tensile forceapplied to the skin, as described above. The outlets 130 of bothreceptacle 100 for male urine and second receptacle 200 for male fecesmay be operably connected so that single outlet tube can serve bothreceptacles.

With reference to FIG. 3, apparatus 400 for detecting fecal matter is anoptional device which may be incorporated into receptacle 100 or 200 forpatient applications involving significant fecal excretion rates.Apparatus 400 extends from the exterior surface to the interior surfaceof receptacle 100 and comprises detector chamber 420 and detector porousend 410. A first end of detector chamber 420 is fluidly connected with avacuum source at the exterior surface of receptacle 100. A second end ofdetector chamber 420 is in fluid communication with porous end 410.Porous end 410 fluidly connects detector chamber 420 to the interior ofreceptacle 100. Vacuum is applied to an internal region of detector 420creating a flow of air from the interior of receptacle 100 throughporous end 410. Pore size of porous end 410 is selected so that anyconcentration of air, water, urine or mist flowing through porous end410 will result in an internal vacuum level below a set point. In theevent that fecal matter accumulates on the outer surface of porous end410, the pressure difference across porous end 410 increases. Thisincreased pressure drop is attributed to the fecal matter having agreater viscosity than the air and/or water and/or urine and/or mistthat is drawn through the porous end during a normal detection interval.This increase in pressure drop across porous end 410 results in aninternal vacuum level above the set point thus initiating a flush cycleof interior region 430 of receptacle 100. During the flush cycle, washfluid 115 is introduced through nozzle 120.

With reference to FIG. 4, apparatus 10 for the removal and containmentof human waste products attaches and seals excrement collection device500, such as, but not limited to, an ostomy bag, to the human body(exterior skin) and may comprise first surface of interface flange 160permanently or removably attached to an opening in excrement collectiondevice 500. Interface flange 160 and excrement collection device 500form a unit wherein a second or interior surface of interface flange 160attaches to the patient's skin around the circumference of an opening inthe patient's body, such as, but not limited to, a stoma. Device 500 isattached to flange 160 to enable collection of fluids, gasses, and/orcontaminants emanating from the patient's body. Another embodiment ofapparatus 10 may comprise a single unit where interface flange 160 is anintegral part of excrement collection device 500. The second or interiorsurface of interface flange 160 is attached to the patient's skin usingvacuum connection 140 that extends from the interior surface to anexterior surface of flange 160, the exterior surface disposed betweenthe patient's skin and device 500 and could be supplemented by adhesiveand/or a belt to enhance support. The vacuum-to-skin interface comprisesvacuum dispersion membrane 150 to support the skin so as to minimizetensile force applied to the skin while allowing the vacuum to attachthe interior surface of flange 160 to the patient's skin. This featureis one aspect to avoiding injury to the skin.

Access port 550 may be disposed on an exterior surface of flange 160 inorder to introduce antimicrobial, moisturizing and/or liquid barriersolutions and/or a connection point for adsorbent to contain odors. Inone embodiment, vacuum connection 140 may comprise an integral vacuumcontrol unit, comprised of a micro vacuum pump, switch, check valve andvacuum control switch/sensor (not shown) may be integrated as part ofinterface flange 160 so that vacuum can be supplied without tether of aseparate vacuum source.

It will be apparent to those skilled in the art that variations andmodifications of the present invention can be made without departingfrom the scope or spirit of the invention. Thus, it is intended that thepresent invention cover all such modifications and variations of theinvention, provided they come within the scope of the appended claimsand their equivalents.

What is claimed is:
 1. An apparatus comprising: a flange surrounding astoma of a patient, the flange having a first surface and an exteriorsurface, wherein the first surface is coupled with skin of the patientaround the stoma; a vacuum connection extending from the exteriorsurface to the first surface of the flange; and a vacuum dispersionmembrane disposed, at least in part, between the vacuum connection andthe skin of the patient around the stoma, wherein the vacuum connectionis adapted to apply vacuum between at least a portion of the firstsurface of the flange and the skin of the patient around the stomathrough the vacuum dispersion membrane, such that the stoma is notexposed to the vacuum; a collection device, the collection device beingcoupled with the flange and at least partially enclosing the stoma; andan inlet extending from the exterior surface to an interior surface ofthe flange for introducing a flushing fluid to an interior of thecollection device, the interior surface being at least partiallyenclosed by the collection device.
 2. The apparatus of claim 1, whereinthe collection device is an ostomy bag.
 3. The apparatus of claim 1,further comprising a vacuum control unit coupled with the vacuumconnection for maintaining a vacuum level of the vacuum applied throughthe vacuum dispersion membrane within a predetermined range.
 4. Theapparatus of claim 3, wherein the vacuum control unit comprises at leastone of a vacuum pump configured to apply the vacuum through the vacuumdispersion membrane, a check valve, or a vacuum control switch.
 5. Theapparatus of claim 1, wherein the vacuum dispersion membrane comprisesat least one of polymer, textile, or synthetic material.
 6. An apparatuscomprising: a flange surrounding a stoma of a patient, the flange havinga first surface and an exterior surface, wherein the first surface iscoupled with skin of the patient around the stoma; a collection devicecoupled with the flange, the collection device at least partiallyenclosing the stoma; a vacuum connection extending from the exteriorsurface to the first surface of the flange; and a vacuum dispersionmembrane disposed, at least in part, between the vacuum connection andthe skin of the patient around the stoma, wherein the vacuum connectionis adapted to apply vacuum between at least a portion of the firstsurface of the flange and the skin of the patient around the stomathrough the vacuum dispersion membrane, such that the stoma is notexposed to the vacuum; and an inlet extending from the exterior surfaceto an interior surface of the flange for introducing a flushing fluid toan interior of the collection device, the interior surface being atleast partially enclosed by the collection device.
 7. The apparatus ofclaim 6, further comprising one or more nozzles in fluid communicationwith the inlet for dispersing the flushing fluid within the collectiondevice.
 8. The apparatus of claim 6, further comprising a vacuum controlunit coupled with the vacuum connection for maintaining a vacuum levelof the vacuum applied through the vacuum dispersion membrane within apredetermined range.
 9. The apparatus of claim 8, wherein the vacuumcontrol unit comprises at least one of a vacuum pump configured to applythe vacuum through the vacuum dispersion membrane, a check valve, or avacuum control switch.
 10. The apparatus of claim 6, further comprisinga human waste detector for sensing presence of human waste in thecollection device.
 11. The apparatus of claim 6, further comprising anoutlet in the collection device allowing at least one of fluids, gasses,or contaminants to exit the collection device.
 12. A method comprising:disposing a flange around a stoma of a patient, the flange having afirst surface coupled with skin of the patient around the stoma, anexterior surface, a vacuum connection extending from the exteriorsurface to the first surface of the flange, and a vacuum dispersionmembrane disposed, at least in part, between the vacuum connection andthe skin of the patient around the stoma; applying, via the vacuumconnection, vacuum between at least a portion of the first surface ofthe flange and the skin of the patient around the stoma through thevacuum dispersion membrane, such that the stoma is not exposed to thevacuum; and introducing a flushing fluid to an interior of a collectiondevice, the collection device being coupled with the flange and at leastpartially enclosing the stoma.
 13. The method of claim 12, furthercomprising dispersing the flushing fluid within the collection device.14. The method of claim 12, further comprising mixing the flushing fluidwith air.
 15. The method of claim 12, further comprising draining atleast one of fluids, gasses, or contaminants from the collection device.16. The method of claim 12, further comprising detecting presence ofhuman waste in a collection device, the collection device being coupledwith the flange and at least partially enclosing the stoma.
 17. Themethod of claim 12, further comprising maintaining a vacuum level of thevacuum applied through the vacuum dispersion membrane within apredetermined range.